Parmodia
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A variety of multiple risk factors including dyslipidemia lead to the development and progression of atherosclerosis proven by many research findings including the Framingham Study. Especially, a type of dyslipidemia characterized by "increased triglyceride (TG)-rich lipoproteins," "increased small dense LDL particles," and "decreased HDL-C" is associated with a high risk of atherosclerosis and frequently present in patients with metabolic syndrome or type 2 diabetes.
Peroxisome proliferator-activated receptor α (PPARα) agonists, nicotinic acid derivatives, and EPA preparations are used to treat dyslipidemia with high TG and low HDL-C levels.On the other hand, statins are recommended for dyslipidemia with high LDL-C. However, even if LDL-C is controlled with statins, other lipids may not be adequately controlled so that the risk of atherosclerosis remains, where the management of TG and HDL-C is also considered important.
Therefore, there was a need for development of novel agent with fewer restrictions on use and improved benefit risk balance, providing the motivation of increasing benefit and reducing risk of PPARα agonists.Parmodia® Tablets 0.1 mg has been developed as to be selective PPARα modulator (SPPARMα), improving lipid metabolism by selectively modulating the expression of genes involved in lipid metabolism mainly in the liver through ligand-specific conformational changes of its nuclear receptor, PPARα, after binding.
Clinical pharmacology studies were conducted to investigate pharmacokinetic interactions with various statins and pharmacokinetics in patients with renal or hepatic dysfunction.
Potent fasting serum TG-lowering action, HDL-C increasing action, and sustained long-term effects of them were shown in clinical studies, such as a dose-finding study, comparative confirmatory studies with fenofibrate, and long-term studies in dyslipidemia patients with high TG levels and in patients with type 2 diabetes and dyslipidemia.